Endoscopic and Transesophageal Oropharyngeal Airway

ABSTRACT

An oropharyngeal airway for use during diagnostic and surgical procedures, comprising a body with a proximal and a distal end. The distal end is sized for insertion through a protective bite block disposed in a patient&#39;s mouth. Both sides of the distal end are tapered to a curved distal edge. A flange is transversely opposed at the proximal end, preventing the proximal end from moving through the protective bite block and into the patient&#39;s mouth. An elliptically-arched channel in the shape of a lingual contour extends from the proximal end to the distal end. The channel includes a pair of tapered upstanding walls that guide the passage of a surgical instrument through the space between them. The oropharyngeal airway can be constructed of recyclable or biodegradable materials and is compatible with protective bite blocks of all sizes.

CROSS-REFERENCE TO RELATED APPLICATIONS

Not Applicable

STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT

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REFERENCE TO SEQUENCE LISTING, A TABLE, OR A COMPUTER PROGRAM LISTING COMPACT DISK APPENDIX

Not Applicable

ABSTRACT

An oropharyngeal airway for use during diagnostic and surgical procedures, comprising a body with a proximal and a distal end. The distal end is sized for insertion through a protective bite block disposed in a patient's mouth. Both sides of the distal end are tapered to a curved distal

CONFIDENTIAL edge. A flange is transversely opposed at the proximal end, preventing the proximal end from moving through the protective bite block and into the patient's mouth. An elliptically-arched channel in the shape of a lingual contour extends from the proximal end to the distal end. The channel includes a pair of tapered upstanding walls that guide the passage of a surgical instrument through the space between them. The oropharyngeal airway can be constructed of recyclable or biodegradable materials and is compatible with protective bite blocks of all sizes.

FIELD OF THE INVENTION

Aspects of the invention relate to the establishment and maintenance of a patent airway during minimally invasive surgery, and, more particularly, to oropharyngeal airway devices used for such minimally invasive surgery.

BACKGROUND OF THE INVENTION

The demand for the administration of anesthesia during minimally invasive surgery, in which a surgical instrument is disposed in the patient's upper airway, such as the esophagus or the airway structures distal to the glottic opening, and a protective bite block is placed into the mouth opening, has created airway maintenance issues that were not routinely encountered when these procedures were conducted with low level sedation or no sedation at all.

After induction of an anesthetic, particularly intravenous general anesthesia, upper airway tone is relaxed to such an extent that the upper airway may be blocked, preventing the anesthetized patient from spontaneously breathing. Specifically, the tongue typically relaxes in such a manner as to block the flow of air into and out of the lungs. Thus the airway is not patent.

In an effort to overcome this upper airway relaxation and to ensure that an anesthetized patient continues to spontaneously breathe, mechanical rescue maneuvers are often employed. If successful, a mechanical maneuver, such as a jaw thrust or a chin lift, which entails lifting the patient's chin and extending the neck, may encourage the relaxed tongue to move into a position anterior and superior to the glottic opening, thus allowing the free movement of air during spontaneous ventilation. The jaw thrust and other mechanical rescue maneuvers, however, are frequently unsuccessful in establishing and maintaining a patent airway. Depending on the depth of the anesthetic employed, the combination of pharmacologic agents administered, and the size of the patient's tongue, these mechanical rescue maneuvers may not ensure that the patient's airway will be established, remain patent, and that the patient will be able to spontaneously breathe.

During minimally invasive surgery, such as esophagogastroduodenoscopy, transesophageal echocardiography, or bronchoscopy, in which a surgical instrument, including fiberoptic scopes or ultrasound probes, is disposed in the patient's upper airway, a protective bite block is placed into the mouth opening. Such a bite block is placed between the upper and lower teeth acting as a barrier preventing injury to the patient's dentition and damage to the surgical instrument. Typically, a tubular access hole in the middle of the protective bite block allows for the passage of a surgical instrument into the oral cavity. The bite block is placed into the patient's mouth opening before the induction of an anesthetic; during this time, the patient is conscious and able to follow commands such as to open and close the mouth. The bite block does not incorporate a tongue blade to displace the tongue away from the glottic opening, so the gag reflex is not initiated. If the gag reflex were initiated, the disposition of a surgical instrument would be significantly impeded and the procedure uncomfortable for the patient to endure. However, after a protective bite block is in place and the induction of anesthesia has commenced, an anesthetized patient's gag reflex is obtunded, and the patient is thus typically able to comfortably tolerate the disposition of a surgical instrument into the upper airway, including but not limited to the esophagus or the airway structures distal to the glottic opening.

During minimally invasive surgery, the relaxed tongue of an anesthetized patient may obstruct the movement of air into and out of the glottic opening. When this occurs, the jaw thrust or chin lift rescue maneuvers may be employed to displace the relaxed tongue and to reestablish a patent airway, thereby allowing for spontaneous patient ventilation. In the event that these rescue maneuvers do not provide for the reestablishment and maintenance of a patent airway, the minimally invasive surgery must be abandoned, necessitating the complete removal of the surgical instrument from the oral cavity. Further, in order to reestablish the patent airway, an airway device must be inserted into the oropharyngeal cavity to displace the tongue away from the glottic opening.

Oral airway devices designed for insertion into the oropharyngeal cavity to displace the relaxed tongue away from the glottic opening often may not used with a protective bite block and surgical instrument in place. During minimally invasive surgery, including esophagogastroduodenoscopy, transesophageal echocardiography, or bronchoscopy, a protective bite block is placed into the mouth opening, and a surgical instrument, such as a fiberoptic scope or ultrasound probe, is disposed in the patient's upper airway. Oral airway devices may not be used in such minimally invasive surgery, because they will not physically fit into the mouth opening while a protective bite block and a surgical instrument are in place.

Further, the insertion of said oral airway devices through a protective bite block is difficult and often impossible due to size incompatibility with the bite block. To force the insertion of a larger than compatible airway device may cause physical harm to the patient's dentition and oropharyngeal airway structures. In practice, these incompatible oral airway devices may only be inserted, after removal of the surgical instrument and bite block, either with the aid of a tongue depressor or an upside-down insertion maneuver and 180-degree rotation into a position that displaces the relaxed tongue superior and anterior to the glottic opening. If the bite block were left in place in the patient's mouth opening, the use of a tongue depressor would likely cause injury to the side of the patient's mouth, because there is limited space between the side of the mouth and the bite block. Alternatively, the 180-degree rotation method, with the bite block in place, would also be hazardous, as damage to the roof of the patient's mouth would likely occur. Thus, there is a need for an oropharyngeal airway capable of safe insertion, while both a bite block and a surgical instrument are in place, without risking damage to a patient's mouth surface, dentition, or upper airway structures.

Further, existing oral airway devices are generally constructed of non-recyclable and non-biodegradable materials and are disposed of after a single use. The demand for the administration of anesthesia during minimally invasive surgery, and the frequency with which it is performed creates a need for a recyclable and biodegradable oropharyngeal airway.

For the safe and environmentally friendly administration of anesthesia during minimally invasive surgery, including but not limited to an esophagogastroduodenoscopy, transesophageal echocardiography, or bronchoscopy, such that the procedure would not have to be abandoned in order to reestablish a patent airway, there is a need for an oropharyngeal airway device compatible with a protective bite block and preferably composed of a recyclable or biodegradable material, that will allow for the maintenance of a patent airway and spontaneous ventilation.

BRIEF SUMMARY OF THE INVENTION

An oropharyngeal airway provides for the establishment and maintenance of a patent airway during the delivery of an anesthetic while a patient is undergoing minimally invasive surgery in which a surgical instrument is disposed in the upper airway, and a protective bite block is placed into the mouth opening.

An oropharyngeal airway includes:

A tapered body having a distal and a proximal end for insertion of only the distal end of the device through the tubular access hole of a protective bite block.

An uninterrupted channel, curved from proximal end to distal end, mimicking the lingual curve. In some embodiments the channel is U-shaped.

The oropharyngeal airway features an elliptically arched channel, mimicking the lingual curve, such that it may be safely inserted straight forward, without the use of a tongue depressor or any need for rotation, techniques which create serious risk of injury to a patient's mouth surface, dentition, and upper airway structures. Further, the arched channel allows for disposition of the oropharyngeal airway so as to avoid pushing the tongue downward, obstructing the glottic opening, therefore establishing a patent airway once inserted.

The oropharyngeal airway of the present invention may also be composed of any suitable recyclable and/or biodegradable material, such as a starch-based biodegradable polymer.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of an oropharyngeal airway;

FIG. 2 is a perspective view showing the oropharyngeal airway of FIG. 1 disposed into a typical protective bite block;

FIG. 3 is a side elevation view of an oropharyngeal airway;

FIG. 4 is a side elevation view showing the oropharyngeal airway of FIG. 3 disposed into a typical protective bite block;

FIG. 5 is a front elevation view of an oropharyngeal airway;

FIG. 6 is a front elevation view showing the oropharyngeal airway of FIG. 5 disposed into a typical protective bite block;

FIG. 7 is a top down view showing an oropharyngeal airway disposed into the typical protective bite block;

FIG. 8 is a profile view showing an oropharyngeal airway disposed in a typical protective bite block, placed in a patient's mouth opening with a surgical instrument concurrently disposed.

DETAILED DESCRIPTION OF THE INVENTION

It is understood that this description and the accompanying drawings illustrate aspects and embodiments of the present invention and are not limiting. Nor is the present invention limited to the use in the context suggested by the background section.

Further, the terminology in this description is not intended to limit the invention. As used herein, the term “minimally invasive surgery” includes esophagogastroduodenoscopy, transesophageal echocardiography, bronchoscopy, or any other diagnostic or surgical procedure in which a surgical instrument is disposed in the oral cavity. Also as used herein, the term “surgical instrument” includes any one or more of flexible optical scopes, fiberoptic scopes, videoscopes, ultrasound probes, or other types of devices or combinations thereof, that are capable of performing functions ascribed to or associated with the surgical instrument.

Referring now to the drawings in detail and particularly to FIGS. 1 and 3, there is shown one embodiment of an oropharyngeal airway 10 with an elongated, U-shaped channel 22, a transversely opposed flange 14 at the proximal end 12, and having a tapering distal end 32. At the proximal end 12 and adjacent transversely opposed flange 14, there is a channel opening 20. In some embodiments, the airway 10 may be constructed of any suitable material, such as metal or plastic. In other embodiments, the airway may be constructed of any suitable recyclable or biodegradable material, such as a starch-based biodegradable polymer. Various embodiments of airway 10 can be in different sizes to accommodate protective bite blocks from different manufacturers and of differing sizes for use with patients of all ages and dimensions.

One embodiment of the airway 10, shown in FIGS. 1, 3, 7, and 8, has an elliptically arched contour 28 that allows for the positioning of the tongue 303 in such a fashion as to establish and maintain a patent airway. The elliptically arched contour mimics the lingual curve such that the airway may be safely inserted straight forward, without the use of a tongue depressor or any need for rotation, thus diminishing the risk of injury to a patient's mouth surface, dentition, and upper airway structures. Further, the embodiment's arched channel allows for disposition of the oropharyngeal airway so as to avoid pushing the tongue downward, obstructing the glottic opening, and therefore establishing a patent airway once inserted.

Embodiments of the airway 10 include .a tapered distal end 32 that allows for disposition of the distal end into the oropharyngeal cavity, while displacing the base of the tongue away from the glottic opening. The tapered distal end 32 allows for the tongue 303 to be moved anterior and superior to establish and maintain a patent glottic opening 306. An upstanding wall 16 extends from each side of the lingual surface 18 and is secured to the transversely opposed flange 14, as shown in FIGS. 1, 3, and 5. Upstanding wall 16 extends from each side from flange 14 to distal end 32, allowing and guiding the passage of a surgical instrument. In one embodiment, the height of upstanding wall 16 is consistent from points 12 to 24, and tapers along longitudinal, elliptical contour 26 from point 24 to distal end 32, shown in FIGS. 1 and 3.

Referring now to FIGS. 5, 6, and 7, there is shown a radius taper 34 on both sides of the distal end 32 that forms a smooth distal edge and allows for the disposition of the airway 10 into the oropharyngeal cavity 300, shown in FIG. 8, without causing injury to contacted anatomical structures.

Referring now to FIGS. 2, 4, 6, 7, and 8, the airway 10 is shown disposed into a typical protective bite block 101. The oropharyngeal airway may be disposed into the oropharyngeal cavity while a protective bite block is in place at the mouth opening and either immediately preceding or anytime after insertion of a surgical instrument.

Referring now to FIGS. 1, 2, 5, 6, and 8, channel opening 20, the U-shaped channel 22, elliptical contour 26, and elliptically arched contour 28 allow the airway to be disposed into the oropharyngeal cavity during any said minimally invasive surgery with a protective bite block 101 disposed in the patient's mouth opening and a surgical instrument 200 in place.

Referring now to FIGS. 2, 4, 6, and 8, there is shown a structure consistent with a typical protective bite block 101. The patient's upper teeth or gums 301 rest on surface 101A, while the patients lower teeth or gums 302 rest on surface 101B. The surgical instrument 200 is introduced and disposed through the tubular access hole 101C into the oropharyngeal cavity 300 and the esophagus 305. The distal surface of flange 14 rests on the outer plane 101D, preventing disposition of the entire airway 10 into the oral cavity. In one embodiment, the oropharyngeal airway includes a U-shaped flange, at the proximal end, which prohibits the proximal end from moving through the bite block and into the oral cavity

Referring now to FIG. 8, the human profile shown demonstrates the disposition of the airway 10 in the oropharyngeal cavity 300 with protective bite block 101 disposed at the mouth opening and a surgical instrument 200 disposed in the esophagus 305.

Numerous characteristics, advantages, and embodiments of the invention have been described in detail in the foregoing description with reference to the accompanying drawings. However, the above description and drawings are illustrative only. The present invention is not limited to the illustrated embodiments, and all embodiments of the invention need not necessarily achieve all of the advantages or purposes, or possess all characteristics, identified herein. One skilled in the art may effect various changes and modifications without departing from the scope or spirit of the present invention. Although example materials have been provided, the invention is not limited to such materials unless specifically required by the language of a claim. The elements and uses of the above=described embodiments can be rearranged and combined in manners other than specifically described above, with any and all permutations within the scope of the invention. The present invention should not be limited to any single embodiment, but rather should be constructed in breadth and scope in accordance with the recitation of the appended claims. 

1. An oropharyngeal airway comprising: a body comprising a distal end and a proximal end, wherein the body is of such dimensions that the distal end is capable of insertion through an access hole of a protective bite block and is disposed into a patient's oropharyngeal cavity, and the proximal end is disposed at the patient's mouth opening; an elliptically-arched channel coupled to the body, wherein the elliptically-arched channel is curved to mimic the lingual contour and extends between the proximal end and the distal end of the body; and at least one pair of upstanding walls coupled to the body, wherein the at least one pair of upstanding walls extends longitudinally down a lingual surface of the elliptically-arched channel, from the proximal end to the distal end of the body, and wherein the at least one pair of upstanding walls provides a region of radial separation between each upstanding wall of the at least one pair of upstanding walls.
 2. The oropharyngeal airway of claim 1, wherein the elliptically-arched channel has a generally U-shaped cross-section.
 3. The oropharyngeal airway of claim 1, wherein the height of the at least one pair of upstanding walls tapers along a longitudinal, elliptical contour.
 4. The oropharyngeal airway of claim 1, wherein each side of the distal end has a radius taper, such that the distal end has a smooth distal edge.
 5. The oropharyngeal airway of claim 2, wherein the height of the at least one pair of upstanding walls tapers along a longitudinal, elliptical contour. 6-8. (canceled)
 9. The oropharyngeal airway of claim 1, further comprising a flange, wherein the flange is transversely opposed at the proximal end, and wherein the flange is at a location abutting the protective bite block such that the proximal end is prevented from moving through the access hole and entering the patient's oral cavity.
 10. The oropharyngeal airway of claim 1, wherein the oropharyngeal airway is comprised of a recyclable material.
 11. The oropharyngeal airway of claim 1, wherein the oropharyngeal airway is comprised of a biodegradable material. 12-19. (canceled)
 20. The oropharyngeal airway of claim 1, wherein the oropharyngeal airway is comprised of a starch-based biodegradable polymer. 21-37. (canceled) 